NDC 53002-2604

Ofloxacin Otic

Ofloxacin

Ofloxacin Otic is a Auricular (otic) Solution in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Ofloxacin.

Product ID53002-2604_90f6aff2-4d88-4e2f-bb40-7f4c9f7ccf2a
NDC53002-2604
Product TypeHuman Prescription Drug
Proprietary NameOfloxacin Otic
Generic NameOfloxacin
Dosage FormSolution
Route of AdministrationAURICULAR (OTIC)
Marketing Start Date2004-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA076527
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameOFLOXACIN
Active Ingredient Strength3 mg/mL
Pharm ClassesQuinolone Antimicrobial [EPC],Quinolones [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53002-2604-1

5 mL in 1 BOTTLE, DROPPER (53002-2604-1)
Marketing Start Date2018-10-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-2604-1 [53002260401]

Ofloxacin Otic SOLUTION
Marketing CategoryANDA
Application NumberANDA076527
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OFLOXACIN3 mg/mL

OpenFDA Data

SPL SET ID:7592cf3f-7d4b-436f-89f0-a3686570fef8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 242446
  • Pharmacological Class

    • Quinolone Antimicrobial [EPC]
    • Quinolones [CS]

    NDC Crossover Matching brand name "Ofloxacin Otic" or generic name "Ofloxacin"

    NDCBrand NameGeneric Name
    50090-1090Ofloxacin OticOfloxacin
    68071-1588Ofloxacin OticOfloxacin Otic
    68071-1630Ofloxacin OticOfloxacin Otic
    68788-9504Ofloxacin OticOfloxacin Otic
    53002-2604Ofloxacin OticOfloxacin Otic
    60505-0363Ofloxacin OticOfloxacin Otic
    63187-184Ofloxacin OticOfloxacin Otic
    72189-108OFLOXACIN OTICOFLOXACIN OTIC
    11980-779OCUFLOXofloxacin
    0404-7189OfloxacinOfloxacin
    0517-0760OfloxacinOfloxacin
    13985-602OfloxacinOfloxacin
    17478-713OfloxacinOfloxacin
    21695-439OfloxacinOfloxacin
    24208-410OfloxacinOfloxacin
    24208-434OfloxacinOfloxacin
    33261-737OfloxacinOfloxacin
    40042-049OfloxacinOfloxacin
    42254-257OfloxacinOfloxacin
    50090-0891OfloxacinOfloxacin
    50090-1346OfloxacinOfloxacin
    50090-1736OfloxacinOfloxacin
    50090-5186Ofloxacinofloxacin
    50090-5209Ofloxacinofloxacin
    50090-5210Ofloxacinofloxacin
    50090-5425OfloxacinOfloxacin
    50090-5670OfloxacinOfloxacin Otic
    50383-024OfloxacinOfloxacin

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.